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Completed

NCT Number: NCT01559740

Transversus Abdominis Plane Blocks for Infants and Children for Postoperative Pain Control

After undergoing hernia surgery, hydrocelectomy or lower abdominal surgery, a child may experience some amount of pain in the post-operative period. As part of the anesthesia technique, the investigators routinely provide a nerve block done on the abdominal wall that will provide pain relief for at least 10 hours postoperatively. This is referred to as a TAP block. The purpose of this study is to determine if the nerve block performed with local anesthetic solution using a regular concentration solution vs. a diluted solution may offer different durations of pain relief.

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Key information

Age range

Up to 8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

About this study

Children undergoing groin surgery or abdominal surgery under general anesthesia are offered pain relief postoperatively using regional anesthesia techniques including a central block like a caudal block, or peripheral nerve blocks including ultrasound guided ilioinguinal nerve block or transversus abdominis plane (TAP) block. The TAP block, a peripheral block of the thoraco-lumbar nerve roots as they exit between the internal oblique and the transversus abdominis muscle can be easily visualized using ultrasound guidance. The TAP block has been used for analgesia following major surgeries including lower abdominal surgeries and in newborn infants following major abdominal procedures including colostomy placement.1 The purpose of this study is to determine if two different concentrations of bupivacaine delivered at a total dose of 1 mL/kg offer similar or altered analgesia, i.e., does the concentration of the anesthetic matter more than the volume of local anesthetic while performing a TAP block in children undergoing groin surgery. Parents and the investigators will be blinded to the solution used for the TAP block. The solution will be drawn up by an investigator who is not a participant in the patient's care in a sterile fashion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children under 8 years of age presenting for hernia repair, hydrocelectomy or lower abdominal surgery
  • Estimated operative time approximately 3 hours
  • American Society of Anesthesiologists Classification ASA I or II
  • Parental consent to be included in the study

Exclusion criteria

  • Any contraindications to local anesthesia but not limited to
  • Local infection of the abdominal wall.
  • Allergy to amide local anesthetics
  • History of significant cardiac disease or uncontrolled seizures.
  • Allergy to rescue analgesia including acetaminophen and or hydromorphone.
  • Neonates under 28 days.
  • Inability for the family to complete the postoperative questionnaire

Treatment and study plan

Bupivacaine

Drug

This is being used as the local anesthetic for the TAP blocks at either 0.25% or 0.125%. The block will be done once during the procedure.

Primary outcomes

  1. TAP Block Concentration of Bupivacaine that Reduces Postoperative Pain

    Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

    The difference in concentrations will be measured by using FLACC score every 5 mins for one hour after surgery in the Post Anesthesia Care Unit. Blood pressuer and heart rate will also be recorded.

Secondary outcomes

  1. Dose of rescue medications given between the two groups

    Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

    The dose of pain medications administered will be recorded by the nurse or study coordinator while in the hospital. The caregiver will record the dose of pain medications administered in a caregiver questionnaire sheet.

  2. Number of rescue medications given between the two groups

    Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

    The number of pain medications administered will be recorded by the nurse or study coordinator while in the hospital. The caregiver will record the number of pain medications administered in a caregiver questionnaire sheet.

  3. Time the rescue medications were administered between the two groups

    Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

    The time pain medications administered will be recorded by the nurse or study coordinator while in the hospital. The caregiver will record the time pain medications administered in a caregiver questionnaire sheet.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Transversus Abdominis Plane Blocks for Infants and Children for Postoperative Pain Control: Is it the Concentration or Volume of Local Anesthetic Solution That Improves Analgesia?

Important dates

Study start
2010
Primary completion
2010
First posted
Mar 21, 2012
Registry last updated
Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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